Pro-inflammatory Cytokines in Case of Essure®
- Conditions
- Inflammatory Disease
- Interventions
- Other: pro-inflammatory cytokines
- Registration Number
- NCT05944822
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.
The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.
Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.
The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- women over 18
- intervention between January 2021 and November 2022
- person having expressed his non-opposition
Essure group : patient who underwent removal of the Essure® contraceptive implant
Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis
Control with endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control with endometriosis/adenomyosis pro-inflammatory cytokines patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis Essure pro-inflammatory cytokines patient who underwent removal of the Essure® contraceptive implant Control with no endometriosis/adenomyosis pro-inflammatory cytokines patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis
- Primary Outcome Measures
Name Time Method cytokine IL10 in peritoneal fluid through study completion, an average of 4 months Level of cytokine IL10 in peritoneal fluid
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
🇫🇷Bron, France